FDA Registration
Active
🇺🇸 United States
NORTECH SYSTEMS, INC.
Reg #: 2183613
·
FEI: 2183613
·
Expires 2026
Products
22
Proprietary Names
22
Establishment Types
1
Classifications
22
Registration Details
- Registration Name
- NORTECH SYSTEMS, INC.
- Registration Number
- 2183613
- FEI Number
- 2183613
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 925 SIXTH AVENUE NE
- City
- Milaca
- State
- MN
- ZIP
- 56353
- Country
- US
Owner / Operator
- Firm Name
- Nortech Systems, Inc.
- Operator Number
- 10032390
- Address
- 925 6th Ave NE
- City
- Milaca
- State
- MN
- Postal Code
- 56353
- Country
- US
- Correspondent
- Albert Schafer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2017-03-01 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2020-02-28 |
| Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | PGT | Class 2 | Obstetrics/Gynecology | No | 2024-09-03 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2021-02-25 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2016-08-11 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2018-08-16 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-01-11 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2022-12-13 |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2014-02-05 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-01-09 |
| Wound Cleaner, Ultrasound | NRB | Class 2 | General, Plastic Surgery | No | 2024-09-03 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-09-03 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-09-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-09-03 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2024-09-03 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2024-09-03 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2014-02-05 |
| Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | NAM | Class 2 | Gastroenterology, Urology | No | 2013-07-08 |
| Stimulator, Hypoglossal Nerve, Implanted, Apnea | MNQ | Class 3 | Unknown | No | 2024-09-20 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2013-05-14 |
| Probe, Uptake, Nuclear | IZD | Class 1 | Radiology | No | 2017-09-18 |
Proprietary Names
EZstim III
COOLIEF Quad Pump
Assist
MS-IVB
CirQPOD
Aerin Console, Model FG226
TELIGEN
mcompass
Mammotome elite Biopsy System
UltraMist
Portrait Clinical Alarming Unit (Portrait CAU01)
BRS
Rezum System
Urgent PC Neuromodulation System
Model 2740 Physician Programmer
SleepSync Model 2740C Inspire Programmer Cable
SleepSync Model 2740S Inspire Programming Software Application
Aerin Console, Model FG2045
PATIENT WARMING SYSTEM M1000 CLEANING KIT
Kimberly-Clark Patient Warming System
Neoprobe
TDA-PPU-1
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)